Press release
Insmed Receives Positive CHMP Opinion for ARIKAYCE Liposomal 590 mg Nebuliser Dispersion for the Treatment of NTM Lung Infections Caused by MAC in Non-CF Patients with Limited Treatment Options
- If Approved, ARIKAYCE Will Be First and Only Therapy in the European Union for This Difficult-to-Treat Condition - - Decision from European Commission
About this update from Insmed Incorporated
[{"type":"text","content":"- If Approved, ARIKAYCE Will Be First and Only Therapy in the European Union for This Difficult-to-Treat Condition -\n - Decision from European Commission Expected Second Half of 2020 -\n\n\nBRIDGEWATER, N.J., July 24, 2020 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending ARIKAYCE Liposomal 590 mg Nebuliser Dispersion for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in adults with limited treatment options who do not have cystic fibrosis. Consideration should be given to official guidance on the appropriate use of antibacterial agents.\nThe European Commission (EC) will review the CHMP opinion, with a final decision anticipated in the second half of 2020. \n\"Today's positive opinion from the CHMP marks an important step in our journey to transform the way MAC lung disease is managed for patients around the world. If approved by the EC, ARIKAYCE would be the first therapy in both the European Union and the United States for patients with this chronic, debilitating condition,\" said Will Lewis, Chairman and Chief Executive Officer of Insmed. \"We look forward to potentially bringing ARIKAYCE to appropriate patients in Europe as quickly as possible.\"\nThe CHMP opinion is based on results from the Phase 3 CONVERT study, which demonstrated that once-daily ARIKAYCE, when combined with multi-drug regimen (MDR), improved sputum culture conversion rates in patients with refractory NTM lung disease caused by MAC compared to MDR therapy alone. \n\"The positive CHMP opinion underscores the potential benefit of ARIKAYCE in the management of MAC lung disease for patients who are particularly difficult to treat and continue to suffer in the absence of an approved therapy in Europe,\" said Prof. Dr. Christoph Lange, Medical Director of Clinical Infectious Diseases at the Medical Clinic of the Research Center Borstel, Leibniz Lung Center, Germany. \"As demonstrated in the Phase 3 CONVERT study, ARIKAYCE has the potential to improve culture-conversion rates in patients with MAC lung disease who were not respo...